Cleared Traditional

Newclip Patient-matched instrumentation non sterile PSI

K240415 · Newclip Technics · Orthopedic

Nov 2024

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K240415 is an FDA 510(k) clearance for the Newclip Patient-matched instrumentation non sterile PSI, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by Newclip Technics (Haute Goulaine, FR). The FDA issued a Cleared decision on November 7, 2024, 269 days after receiving the submission on February 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K240415 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2024
Decision Date	November 07, 2024
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PBF — Orthopaedic Surgical Planning And Instrument Guides
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.